Bioregulatory Consulting

About Bioregulatory Consulting

Bioregulatory Consulting (BRC) provides a specialised regulatory and development service to the biotechnology and pharmaceutical industries. BRC is a privately held company, based in Melbourne, which was founded in February 2002. BRC offers professional advice and scientific writing to assist with the development and registration of prescription medicines. It has provided regulatory advice on:

• monoclonal antibodies including targets against VEGF-A and EGFR
• both therapeutic and prophylactic HIV vaccines
• Immunotherapeutics, including the use of gene therapies, in oncology indications
• E.coli derived recombinant proteins such as: interleukin-1 receptor antagonist (IL-1RA), recombinant insulin, human growth hormone (rhGH), pegylated interferon alpha 2 and human granulocyt colony stimulating factor (rhG-CSF)
• Cell culture derived recombinant proteins including human erythropoietin (rhEPO),
• Cell therapies including allogeneic Mesenchymal Stem Cells and Chimeric Antigen Receptor T-Cell (CAR-T)
• Vaccines against pertussis, diphtheria, tetanus and influenza.

BRC has scientific understanding and regulatory expertise in the chemistry, manufacturing and controls (CMC) aspects of vaccines, biopharmaceuticals and biologicals. This proficiency has enabled successful global regulatory submission for both clinical trials and registration applications.